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Effects of Different Continuous Renal Replacement Therapy Patterns on Ionized Calcium in Patients With Citrate Anticoagulants Using Calcium-containing Replacement Solutions

Sponsor
Fujian Provincial Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06021080
Collaborator
(none)
30
Enrollment
1
Location
18
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

It is unclear whether different modes of continuous renal replacement therapy (CRRT) impact post-filter ionized calcium concentrations during regional citrate anticoagulation (RCA) when using calcium-containing replacement fluid.

This prospective, single-center, observational cohort study will screen all patients receiving CRRT for eligibility. General clinical information will be collected before commencing CRRT treatment. Patients will be randomly assigned to either the veno-venous hemofiltration (CVVH) or continuous veno-venous hemodialysis (CVVHD) group and switch to the alternative mode in the subsequent treatment session. Pre-filter and post-filter ionized calcium, systemic total and ionized calcium, and effluent total and ionized calcium will be measured 2 hours after the initiation of CRRT. Electrolyte levels, arterial blood gases, hourly citrate dose, and total citrate dose will be recorded every 6 hours until the end of CRRT. The primary outcome is the difference in ionized calcium concentrations at each site over time between the two modes.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Case-Crossover
    Time Perspective:
    Prospective
    Official Title:
    Effects of Different Continuous Renal Replacement Therapy Patterns on Ionized Calcium in Patients With Citrate Anticoagulants Using Calcium-containing Replacement Solutions
    Actual Study Start Date :
    Jun 9, 2023
    Anticipated Primary Completion Date :
    Jun 9, 2024
    Anticipated Study Completion Date :
    Dec 9, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    CVVHD

    Continuous Veno-Venous Hemosdialysis
    CVVH

    Continuous Veno-Venous Hemofiltration

    Outcome Measures

    Primary Outcome Measures

    1. Post-filter iCa [2 hours after the initiation of CRRT]

      The post-filter ionized calcium concentration

    2. Serum iCa [2 hours after the initiation of CRRT]

      Serum ionized calcium concentration

    3. Serum Ca2+ [2 hours after the initiation of CRRT]

      Serum total calcium concentration

    4. Effluent Ca2+ [2 hours after the initiation of CRRT]

      Effluent total calcium concentration

    Secondary Outcome Measures

    1. Incidence of new-onset metabolic complications [48 hours after the initiation of CRRT]

      Including hypercalcemia, hypocalcemia, metabolic acidosis, metabolic alkalosis, citrate accumulation, hypernatremia, and hyponatremia

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Age ≥ 18 years old; 2) Receiving citrate anticoagulation; 3) Obtain Informed consent from patients or next of kin.
    Exclusion Criteria:
    1. Pregnant or lactating women; 2) Allergic to citrate anticoagulants; 3) Severe liver dysfunction (total bilirubin levels exceeding two times the normal range); 4) Hypoxemia (PaO2 < 60 mmHg); 5) Inadequate tissue perfusion (blood pressure < 90/60 mmHg despite high doses of vasoactive agents); 6) Hyperlactatemia (lactate> 4 mmol/L); 7) Hypernatremia; 8) Estimated length of hospital stay < 48h; 9) Participated in other studies.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fujian Provincial Hospital Fuzhou Fujian China 350001

    Sponsors and Collaborators

    • Fujian Provincial Hospital

    Investigators

    • Principal Investigator: Han Chen, Ph.D., M.D., Fujian Provincial Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Han Chen, Deputy chief physician, Fujian Provincial Hospital
    ClinicalTrials.gov Identifier:
    NCT06021080
    Other Study ID Numbers:
    • HChen
    First Posted:
    Sep 1, 2023
    Last Update Posted:
    Sep 1, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Han Chen, Deputy chief physician, Fujian Provincial Hospital
    Renal Injury
    Regional citrate anticoagulation
    Continuous renal replacement therapy

    Study Results

    No Results Posted as of Sep 1, 2023